FDA.reportPublic FDA data

Application 017001

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANCOBONFLUCYTOSINECAPSULE;ORAL250MGYesNo
002ANCOBONFLUCYTOSINECAPSULE;ORAL500MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-3554ANCOBONFlucytosineBausch Health US LLCNDACurrent
0187-3554ANCOBONFlucytosineValeant Pharmaceuticals North America LLCNDACurrent
0187-3554ANCOBONFlucytosineBausch Health US LLCNDACurrent
0187-3554ANCOBONFlucytosineBausch Health US LLCNDACurrent
0187-3555ANCOBONFlucytosineBausch Health US LLCNDACurrent
0187-3555ANCOBONFlucytosineBausch Health US LLCNDACurrent
0187-3555ANCOBONFlucytosineValeant Pharmaceuticals North America LLCNDACurrent
0187-3555ANCOBONFlucytosineBausch Health US LLCNDACurrent
42494-339FlucytosineFlucytosineCameron Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
42494-339FlucytosineFlucytosineCameron Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
42494-339FlucytosineFlucytosineCameron Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
42494-339FlucytosineFlucytosineCameron Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
42494-340FlucytosineFlucytosineCameron Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
42494-340FlucytosineFlucytosineCameron Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
42494-340FlucytosineFlucytosineCameron Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
42494-340FlucytosineFlucytosineCameron Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
63629-2147FlucytosineFlucytosineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2147FlucytosineFlucytosineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2147FlucytosineFlucytosineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2148FlucytosineFlucytosineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2148FlucytosineFlucytosineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2148FlucytosineFlucytosineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-9156FlucytosineFlucytosineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-9156FlucytosineFlucytosineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-9157FlucytosineFlucytosineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-9157FlucytosineFlucytosineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-9291FlucytosineFlucytosineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70178SUPPL2022-02-16
70175SUPPL2022-02-16
57609SUPPL2019-02-14
57585SUPPL2019-02-13
50484SUPPL2017-11-25
50365SUPPL2017-11-13
49521SUPPL2017-08-23
525SUPPL2009-05-07
13068SUPPL2006-08-11
10947SUPPL2006-08-11
13067SUPPL2003-05-29
524SUPPL2003-05-29
33214SUPPL2003-05-06
33213SUPPL2003-05-06